MAUDE Adverse Event Report: INVACARE FLORIDA INVACARE(R) PERFECTO2(TM) OXYGEN CONCENTRATOR; GENERATOR, OXYGEN, PORTABLE

Model Number NA:IRC5P

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

This medwatch is being filed out of an abundance of caution.There is no alleged failure of the device.Invacare attempted to obtain further information without success.The patient¿s medical history, reason for requiring supplemental oxygen or what caused the death are unknown.The concentrator and home-fill were delivered to the patient on 2-25-20.According to the patient¿s boyfriend, the patient only used the equipment for a day or so before being admitted to the icu.The patient refused to have back-up oxygen and had signed a waiver stating such.Due to the possible pneumonia diagnosis the dealer placed the concentrator in quarantine.The concentrator will not be returned at this time.This concentrator was manufactured by invacare (b)(4).However, they are no longer in business.The manufacturer of these concentrators has since been transitioned to invacare (b)(4).Therefore, the mdr is being filed under invacare (b)(4).

Event Description

Invacare was made aware of the death of a consumer who was using an irc5p concentrator.There is no alleged failure of the device however, the family insists the device potentially contributed to the patients' acute respiratory failure, pneumonia, and subsequent death.

Manufacturer Narrative

The irc5p concentrator was returned to invacare, where it received an expanded evaluation that was completed on (b)(6)2020.The oxygen concentrator was found to function within specifications.Invacare received the concentrator with a broken interconnect hose in the homefill outlet, which would cause the oxygen to leak.The leak from the homefill outlet will not affect the purity, flow rate or pressure of the oxygen delivered to the end user from the cannula outlet nozzle.Invacare received the homefill with damage noted to the cylinder coupling.The homefill was not tested due to the damage prevented the cylinder from being fully seated.It is unclear when or how, these damages occurred.The dealer states when he received the homefill, the packaging used to return the unit showed significant damage.As such, shipping damage cannot be ruled out as the cause of the damages.The intended function and use of the irc5p oxygen concentrator is to provide supplemental oxygen to patients with respiratory disorders.It is not intended to sustain or support life.It should only be used by a patient that can withstand temporary cessation of oxygen, that is capable of spontaneous breath, and that is able to inhale and exhale without the use of a machine.

Event Description

Invacare was made aware of the death of a consumer who was using an irc5p concentrator.There is no alleged failure of the device however, the family insists the device potentially contributed to the patients' acute respiratory failure, pneumonia, and subsequent death.

• Brand Name: INVACARE(R) PERFECTO2(TM) OXYGEN CONCENTRATOR
• Type of Device: GENERATOR, OXYGEN, PORTABLE
• Manufacturer (Section D): INVACARE FLORIDA; 2101 east lake mary blvd; sanford FL 32773
• MDR Report Key: 9959197
• MDR Text Key: 187604827
• Report Number: 1031452-2020-00011
• Device Sequence Number: 1
• Product Code: CAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:IRC5P
• Device Catalogue Number: IRC5P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 06/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death